Evaluation of the Risk of NSF Following ProHance Injection in Patients With Chronic Kidney Disease - Full Text View

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00600834

Purpose

The objective of this long term study is to prospectively compare the incidence of NSF in two cohorts (Cohort 1- patients with moderate chronic kidney disease eGFR 30-59 and Cohort 2- patients with severe chronic kidney disease or kidney failure eGFR <30).

Condition
Renal Insufficiency

MedlinePlus related topics: Kidney Failure

Drug Information available for: Gadoteridol

U.S. FDA Resources

Study Type:

Observational

Study Design:

Cohort, Prospective

Official Title:

A Prospective Cohort Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 3 to 5 Chronic Kidney Disease Undergoing MRI With the Injection of ProHance

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

To estimate and compare the incidence of NSF in the two cohorts defined. The incidence is defined for each cohort as the number of cases of NSF observed during the follow-up time period over the total number of eligible patients. [ Time Frame: 1, 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Fixed tissue samples

Estimated Enrollment:

1000

Study Start Date:

February 2008

Estimated Study Completion Date:

March 2013

Estimated Primary Completion Date:

March 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 patients with moderate CKD (stage 3, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR comprised between 30 and 59 mL/min/1.73m2)
2 patients with severe CKD or kidney failure (stages 4 and 5, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2).

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

A total of 1000 patients in 2 cohorts who are going to receive or have received PROHANCE during an MRI examination as part of their routine clinical management. The cohorts are defined as:

COHORT 1-

600 patients of any age, with moderate CKD (stage 3, i.e., with eGFR stably comprised between 30 and 59 mL/min/1.73m2);

COHORT 2-

400 patients of any age, with severe CKD or kidney failure (stages 4 and 5, i.e., with eGFR below 30 mL/min/1.73m2).

Criteria

Inclusion Criteria:

COHORT 1

Is going to receive or has received PROHANCE injection during an MRI examination;
Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
Provides written informed consent and is willing to comply with protocol requirements.

OR

COHORT 2

Is going to receive or has received PROHANCE injection during an MRI examination;
Has CKD with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
Provides written informed consent and is willing to comply with protocol requirements.

Exclusion Criteria:

COHORT 1

Has received a GBCA within the past 12 months prior to inclusion in this study;
Has unstable kidney function;
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

OR

COHORT 2

Has received a GBCA within the past 12 months prior to inclusion in this study;
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI;
Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of NSF be suspected.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600834

Contacts

Contact: Ami Saver, BS, CNMT

609-514-2206

ami.saver@diag.bracco.com

Locations

United States, New Jersey
Bracco Diagnostic Inc.	Recruiting
Princeton, New Jersey, United States, 08543

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Pirovano, MD

Bracco Diagnostics, Inc

More Information

Responsible Party:

Bracco Diagnostic Inc. ( Gianpaolo Pirovano, MD )

Study ID Numbers:

PH-106

First Received:

January 15, 2008

Last Updated:

August 8, 2008

ClinicalTrials.gov Identifier:

NCT00600834

Health Authority:

United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Fibrosis
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Nephrogenic Fibrosing Dermopathy
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 07, 2009